The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for French Percutaneous Sheath Introducer.
| Device ID | K830813 |
| 510k Number | K830813 |
| Device Name: | FRENCH PERCUTANEOUS SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-04-28 |